Evaluation Of Fluoride Uptake By Dentine Following Silver Diamine Fluoride Under Resin Modified Glass Ionomer Restoration In Carious Primary Molars
Primary Purpose
Dental Caries
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Silver diamine fluoride
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries focused on measuring Silver Diamine Fluoride, Resin Modified Glass Ionomer, Fluoride Uptake, Carious primary teeth
Eligibility Criteria
Inclusion Criteria:
• Carious primary extracted molars.
- Presence of occlusal or proximal caries.
- Caries extending to dentine.
Exclusion Criteria:
• Presence of restorations.
- Presence of pit and fissure sealant.
- Hypolpastic teeth.
- Severly destructed teeth. Thirty two teeth were collected, but only 20 teeth were eligible according to the inclusion and exclusion criteria. Teeth were then stored in distilled water
Sites / Locations
- Department of Pediatric Dentistry, Faculty of Dentistry, Cairo University
- Faculty of Dentistry, Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group (A) : RMGI restoration without SDF and KI.
Intervention Group (B): Pretreatment with SDF and KI prior to RMGI restoration.
Arm Description
• RMGI restoration without SDF and KI.
• Pretreatment with SDF and KI prior to RMGI restoration.
Outcomes
Primary Outcome Measures
Fluoride uptake into dentine
Fluoride weight percent in dentin under Resin Modified Glass Ionomer Restoration in primary molars
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04777968
Brief Title
Evaluation Of Fluoride Uptake By Dentine Following Silver Diamine Fluoride Under Resin Modified Glass Ionomer Restoration In Carious Primary Molars
Official Title
Evaluation Of Fluoride Uptake By Dentine Following Pretreatment With Silver Diamine Fluoride And Potassium Iodide Under Resin Modified Glass Ionomer Restoration Versus Resin Modified Glass Ionomer Restoration Alone In Carious Primary Molars: (In Vitro Study)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
February 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Dental caries is one of the most common oral diseases of childhood and is considered as a major public health problem especially in areas with poor access to dental care. In a recent cross sectional study carried out in Egypt on 1000 child aged from 3-6 years, it was found that 61.4% of these children had dental caries. In order to avoid serious complications of untreated dental caries such as pain, infections, emergency visits and possibly hospitalization , an effective low cost treatment should be identified particularly in areas with poor dental access.
Studies have proven that silver diamine fluoride (SDF) is a topical fluoride that has the ability to effectively arrest and prevent dental caries.
Detailed Description
It was concluded that fluoride uptake into dentine from conventional GI restorations was not affected in the presence of SDF and KI. It was also mentioned that the results may be different if conditioning is applied not etching and recommended this for future investigation.
Aim: Therefore, the aim of this study is to determine whether carious primary molars treated with SDF and Potassium iodide (KI) prior to placing resin modified glass ionomer (RMGI) restorations will affect the fluoride uptake into primary dentine or not.
Study Setting:
The study was conducted in Pediatric Dentistry and Dental Public Health Department Faculty of Dentistry, Cairo University, Egypt.
Energy Dispersive X-ray analysis with Scanning Electron Microscope (SEM/EDX) measurement analysis was conducted at the National Research Center (NRC), Egypt.
Freshly extracted discarded primary molars were collected from outpatient clinic of Pediatric Dentistry Department, Faculty of Dentistry, Cairo University at the end of every day.
Teeth were then sectioned through the center of the carious lesion mesiodistally using a slow-speed cutting saw with coolant (Isomet 4000, USA) forming two similar halves, so that the 20 molars were sectioned to 40 halves.
Each tooth was placed in a separate container with its 2 halves.
Teeth containers were then randomly allocated either to the control or intervention group.
Control Group: One half empty and the other half with Resin Modified Glass Ionmer (RMGI) only.
Intervention Group : One half empty and the other half SDF+KI+RMGI
After dehydration, teeth were mounted on stubs using double-sided carbon tape, and sputter coated with gold for 20 s using a Turbo molecular pumped coater (QUORUM 150T ES, Laughton, United Kingdom) .
Teeth were then placed in SEM/EDX for fluoride measurement by weight percentage.
Data showed parametric distribution so; it was represented by mean and standard deviation (SD) values. Independent and paired t-tests were used for inter and intragroup comparisons respectively. The significance level was set at p ≤0.05 within all tests. Statistical analysis was performed with R statistical analysis software version 4.0.3 for windows (R Core Team, 2020).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Silver Diamine Fluoride, Resin Modified Glass Ionomer, Fluoride Uptake, Carious primary teeth
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Extracted Discarded Primary Molars divided into CONTROL Group & INTERVENTIONAL Group
Masking
InvestigatorOutcomes Assessor
Masking Description
The principle investigator & co-investigator are masked before assessing the outcomes
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group (A) : RMGI restoration without SDF and KI.
Arm Type
No Intervention
Arm Description
• RMGI restoration without SDF and KI.
Arm Title
Intervention Group (B): Pretreatment with SDF and KI prior to RMGI restoration.
Arm Type
Experimental
Arm Description
• Pretreatment with SDF and KI prior to RMGI restoration.
Intervention Type
Drug
Intervention Name(s)
Silver diamine fluoride
Other Intervention Name(s)
SDF and KI
Intervention Description
a layer of 38% SDF solution was topically applied to the cavity using a micro brush, immediately followed by a saturated Potassium Iodide KI solution using a micro brush also, then a creamy white precipitate was immediately formed, KI was applied until the white precipitate turned clear.
Primary Outcome Measure Information:
Title
Fluoride uptake into dentine
Description
Fluoride weight percent in dentin under Resin Modified Glass Ionomer Restoration in primary molars
Time Frame
2 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
• Carious primary extracted molars.
Presence of occlusal or proximal caries.
Caries extending to dentine.
Exclusion Criteria:
• Presence of restorations.
Presence of pit and fissure sealant.
Hypolpastic teeth.
Severly destructed teeth. Thirty two teeth were collected, but only 20 teeth were eligible according to the inclusion and exclusion criteria. Teeth were then stored in distilled water
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rania Nasr, Assoc. Prof.
Organizational Affiliation
Faculty of Dentistry, Cairo University, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatric Dentistry, Faculty of Dentistry, Cairo University
City
Cairo
ZIP/Postal Code
0022
Country
Egypt
Facility Name
Faculty of Dentistry, Cairo University
City
Cairo
ZIP/Postal Code
0022
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Protocol and Abstract
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Evaluation Of Fluoride Uptake By Dentine Following Silver Diamine Fluoride Under Resin Modified Glass Ionomer Restoration In Carious Primary Molars
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